Z-1609-2013Class II

Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric...

Name: Z-1609-2013 Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric...
Creator: Baxter Healthcare Corp.
Published: 2013-06-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-06-07 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's... on 2013-06-07. FDA classified it as Class II and gives the reason as "Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1609-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-06-27
Terminated: 2014-06-04
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.
Quantity in commerce: 601,230 total
Distribution: Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
Product codes and lots: Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1609-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1609-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1610-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code MEB

K062457Class IIInfusor Small Volume Elastomeric Infusion DevicesBaxter Healthcare Corporation / cleared 2006-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)